Three different methods in pain management and treatment of patients with idiopathic frozen shoulder: supracondylar nerve block (SSNB) together with physiotherapy, intra-articular injection of corticosteroid together with physiotherapy and isolated physiotherapy.
Three different methods in pain management and treatment of patients with idiopathic frozen shoulder: supracondylar nerve block (SSNB) together with physiotherapy, intra-articular injection of corticosteroid together with physiotherapy and isolated physiotherapy.
Design
Randomized clinical trial, with parallel groups, without blinding.
Settings and conduct
non-blinded randomized clinical trial
Participants/Inclusion and exclusion criteria
inclusion criteria: pain at rest and limited ROM for at least 3 months. failure in oral medical therapy for at least 3 months normal finding in shoulder imaging limited forward flexion<100degree, limited external rotation<50%, limited internal rotation.
Exclusion criteria: Evidence of degenerative changes in the shoulder joint and rotator cuff tear. History of previous shoulder surgery, trauma, or drug allergy. History of intra-articular shoulder joint injection.
Range of motion
SPADI (The shoulder pain and disability index)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110809007274N16
Registration date:2018-08-03, 1397/05/12
Registration timing:registered_while_recruiting
Last update:2018-08-03, 1397/05/12
Update count:0
Registration date
2018-08-03, 1397/05/12
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Three different methods in pain management and treatment of patients with idiopathic frozen shoulder: supracondylar nerve block (SSNB) together with physiotherapy, intra-articular injection of corticosteroid together with physiotherapy and isolated physiotherapy.
Public title
Three different methods in pain management of patients with frozen shoulder: nerve block plus physical therapy, intra-articular corton injection plus physical therapy and isolated physical therapy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pain at rest and limited range of motion for at least 3 months duration (stage i & II in Kisner & Colby classification) .
failure in oral medical therapy for at least 3 months
normal finding in shoulder imaging
limited forward flexion<100degree, limited external rotation<50%, limited internal rotation
Exclusion criteria:
Evidence of degenerative changes in the shoulder joint (Glenohumeral arthritis) and rotator cuff tear
History of previous shoulder surgery, trauma, or drug allergy
History of intra-articular or peri-articular shoulder joint injection
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Guilan University of Medical Sciences
Street address
Research vice-chancellor of Guilan university of medical sciences building, Shahid Beheshti blv.
City
Rasht
Province
Guilan
Postal code
4193834881
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.GUMS.REC.1397.046
Health conditions studied
1
Description of health condition studied
Adhesive capsulitis of shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Range of motion
Timepoint
pre-treatment, 2nd, 4th, 6th and 12th weeks post treatment
Method of measurement
Goniometer
Secondary outcomes
1
Description
Measuring pain and disability of the patient from 0 to 100
Timepoint
pre-treatment, 2nd, 4th, 6th and 12th weeks post treatment
Method of measurement
SPADI (The shoulder pain and disability index)
Intervention groups
1
Description
Intervention group1: Physiotherapy group in which all case will receive the PT protocol.
Category
Treatment - Other
2
Description
Intervention group2: IACI (Intra articular corticosteroid injection)+ Physiotherapy: all patient will receive IACI (including 8ml of Lidocaine plus 80mg of Prednisolone Acetate). for all patient in this group the PT protocol will be performed.
Category
Treatment - Drugs
3
Description
Intervention group3: SSNB (Supra scapular nerve block)+ Physiotherapy: all patient will receive SSNB (including 8ml of Lidocaine 1% plus 80mg of Prednisolone Acetate) under the sonography guide. for all patient in this group the PT protocol will be performed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht Poursina Hospital
Full name of responsible person
Mohsen Mardani Kivi MD.
Street address
poursina Crossroads, Poursina hospital
City
Rasht
Province
Guilan
Postal code
4137816357
Phone
+98 13 3331 1178
Email
mardani.kivi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati MD, Research chancellor of Guilan university of medical science
Street address
Research vice-chancellor of Guilan university of medical sciences building, Shahid Beheshti blv.
City
Rasht
Province
Guilan
Postal code
4193834881
Phone
+98 13 3331 1178
Email
mardani@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Guilan University of Medical Sciences